Process Validation of Highly Potent Antidiabetic Tablets of Voglibose 0.2 Mg
DOI:
https://doi.org/10.22270/ajprd.v10i2.1070Keywords:
Voglibose 0.2 mg, Critical process parameter, Critical quality attributes, Process capability index.Abstract
Diabetes mellitus is chronic disorder which affecting number of persons worldwide, alpha glycoside inhibitors like Voglibose is a highly potent and tolerant alpha glycoside inhibitor as compare to other diabetic drugs, the main objective of this process validation is to provide documentary evidence that the manufacturing process of Voglibose Tablet IP 0.2 mg will consistently and reproducibly produce a product, which meets predetermined specifications and quality attributes. The critical process parameter was identified with the help of process capability and evaluated by challenging as per in-house specification. Three initial process validation batches (T17L004, T18L003, T19A013) of same size, method, equipment & validation criteria were taken. As per the process validation protocol critical parameter identified like sifting, dry mixing, wet granulation, drying, sifting and milling, blending &lubrication, compression at different stages and blister packing and evaluated as per process validation protocol. Conclusion: Based on evaluation of manufacturing process and analytical data it is concluded that the employed manufacturing process for Voglibose Tablet IP 0.2 mg shall be consistently& reproducibly produce a product which meeting its predetermined specification and quality attributes, hence it is considered to be validated.
Downloads
References
2. Abhishek Raj, Formulation And In-Vitro Evaluation Of Voglibose Dispersible Tablets, World Journal of Biomedical and Pharmaceutical Sciences, 2016;2:226-230.
3. Bala G, “An Integrated Approach To Process Validation Pharm. Eng”, 1994;14(3): 54-64.
4. Nash R.A, Process “Validation For Solid Dosage forms, PharmTechnology”1993;6(3): 34-37.
5. Nash RA, “The validation of pharmaceutical processes In: Hynes MD ,3 Ed, preparing for FDA pre- Approval inspection”, New York, Marcel Dekhher,1999;161-185
6. Carstensen JT, Rhodes CT,”Sampling in blending validation”, Drug Dev Ind Pharm 1993;19(20):2699-270.
7. Mohan S, Rankeel A, Rehm C, Bhalani V, Kulkarni A, “Unit dose sampling and blend uniformity testing “,Pharm Technol,1997;21(4):116-125
Published
How to Cite
Issue
Section
AUTHORS WHO PUBLISH WITH THIS JOURNAL AGREE TO THE FOLLOWING TERMS:
Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 Unported License. that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).
.